Trials / Active Not Recruiting
Active Not RecruitingNCT02387203
Antibiotic Treatment and Long-term Outcomes of Patients With Pseudomyxoma Peritonei of Appendiceal Origin
Clinical Trial to Define the Effect of Perioperative H. Pylori Eradication With Antibiotic Treatment on Long Term Outcomes of Patients With Pseudomyxoma Peritonei of Appendiceal Origin Undergoing Cytoreductive Surgery/Hyperthermic Intraperitoneal Chemotherapy
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Mercy Medical Center · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the impact of antibiotic therapy on the disease progression and overall survival of patients with Pseudomyxoma Peritonei (PMP).
Detailed description
Single center, open label, historical controlled, phase II study that proposes two courses of standard H. Pylori eradication antibiotic therapy can suppress carcinogenesis and improve the long-term outcomes of patients with PMP. The first course of antibiotics (PrevPac) will be administered before cytoreductive surgery and HIPEC and the second course afterwards. The historical control group will consist of all PMP patients from Mercy Medical Center's Tumor Registry who did not receive perioperative antibiotic treatment. Long-term statistical outcomes will be calculated using the Kaplan-Meier method and Cox proportional hazard ratio to compare pertinent variable. 80 subjects to be enrolled over 2 years, with a 5 year follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PrevPac (Prevacid, Amoxicillin, Clarithromycin) | 30mg Prevacid, 1g amoxicillin, 500mg clarithromycin administered together for oral use, twice daily for 14 days preoperatively and twice daily for 14 days at least 4 weeks postoperatively |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2015-03-12
- Last updated
- 2024-11-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02387203. Inclusion in this directory is not an endorsement.